Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial.

Céline Buffel Du Vaure,Elodie Perrodeau,Philippe Ravaud,Isabelle Boutron

doi:10.1186/1741-7015-12-69

Abstract

BackgroundSystematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians’ confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed.MethodsWe planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study’s aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs’ confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5.ResultsBetween October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs’ confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only.ConclusionsWe found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs’ confidence in the conclusions of the abstracts.Trial RegistrationClinicalTrials.gov identifier: NCT01679873

Highlights

Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts
Treatment B and treatment C combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides >/=150 mg/dL and
Adverse events were similar in the 2 treatment groups

Summary

Introduction

Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. The financial relationship among industry, scientific investigators and academic institutions can affect the presentation and interpretation of clinical trial results [7,8,9,10,11]. To deal with these issues, some initiatives have aimed to increase transparency in medical research. The CONSORT Statement for abstracts recommends reporting the funding source in the abstract of randomized trials and in the full-text articles [15,16]. Treatment B and treatment C combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia

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